This article was created by EcoMundo. EcoMundo is a renowned specialist in regulatory compliance services (REACH, CLP, Cosmetics, Biocides, etc.) and SaaS solutions for regulatory chemical management (FDS, chemical risk, regulatory watch, etc.). EcoMundo helps cosmetic companies throughout the compliance processes of their products all over the world.
For many actors of the European cosmetics & personal care products industry, the Cosmetic Regulation n°1223/2009 is the reference for putting compliant and safe products on the European market. Putting a cosmetic product on the European market requires having a Responsible Person, creating a Product Information File, having a compliant label, carrying out a CPNP notification.
Discover the 5 key steps, recommended by EcoMundo’s experts, to placing your products on the European market:
Step 1: appointment of a Responsible Person
Step 2: control of the product composition
Step 3: creation of the Product Information File (PIF)
Step 4: creation of compliant labels
Step 5: CPNP notification before placing the product on the market
A Responsible Person, or RP, is a natural or legal person established in the European Union acting for all the European countries at once.
In the case where the manufacturer, the importer or the distributor appoint a Responsible Person, the only formalism imposed by Cosmetic Regulation 1223/2009 is that there has to be a written agreement between the parties.
The Responsible Person is:
The Responsible Person can be a legal or natural person: because of the multiplicity of his/her responsibilities, it is often simpler to call on the services of consulting firms specialized in this field, i.e. cosmetology, toxicology, Pharmacy, etc.
The second crucial step to validate before placing your cosmetic products on the market, is to review the composition or formula of your cosmetic product on a regulatory perspective, i.e against the Annexes of the Regulation. Here are some key definitions:
Some ingredients are prohibited, restricted or allowed by the Cosmetic Regulation. You should make sure that the product that you want to place on the market is fully compliant with the Annexes of the Regulation outlining these restrictions.
Annex II: These prohibited substances are classified in Annex II of the Regulation 1223/2009.
CMR substances: The CMR substances (Carcinogenic, Mutagen, Reprotoxic) are listed in Annex VI of the CLP Regulation (EC No 1272/2008), and when they are of categories 2, 1A or 1B, they are prohibited.
Nonetheless, they can be authorized in finished cosmetic products under the following conditions:
These substances are listed in Annex III of the Cosmetic Regulation, which counts about 300 substances. These ingredients can be used in cosmetic products only under the conditions described in the annex (product type, purity criteria, percentage of maximal use, etc.). etc.).
Three functions of ingredients are listed by the Regulation: colorants, preservative agents and UV filters.
These ingredients are authorized if they comply with the Regulation's restrictions and depending on the type of products in which they are contained, the part of the body that is concerned, as well as the concentration of the ingredient in the product.
To check the compliance of the formula of your cosmetic product, you must compare the ingredients to the Annexes of the Regulation. It is important to note that this work must be done on a regular basis, insofar as these annexes are updated several times a year (on an average of three months). It is crucial to conduct a continuous regulatory watch.
Depending on the complexity of your formulas, you may want to use a software that will make the process quicker and more reliable.
Another prerequisite to place your cosmetic product on the EU market is the constitution of the Product Information File (PIF). The PIF has to be made available for the authorities, which can consult it at any time (electronic or paper). The drafting and the keeping of the PIF is mandatory even for cosmetics placed on the market before the entry into force of the Regulation (2013).
The PIF (Product Information File) is a regulatory file which must be:
This description has to enable the reader to identify the product, without ambiguity, and to establish a clear relation between the cosmetic product and its PIF.
This report aims to establish a safety assessment of the cosmetic product on the basis of relevant information. The product safety report must be filled in accordance with Annex I of the Cosmetic Regulation.
Two distinct parts:
The Good Manufacturing Practices come from the ISO standard 22716 published in 2007, providing the guidelines for the production, the storage, and the shipping of cosmetic products.
The PIF must contain a description of the manufacturing conditions and the declaration of compliance with the ISO 22716 Good Manufacturing Practices.
The Claims must comply with Regulation No 655/2013 specifically drafted for the making of claims.
Claims are texts, names, trade marks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have. The proofs of the claims may be: consumer perception test, clinical tests, bibliographic search, properties of ingredients that compose the product.
Animal experimentation is prohibited: the testing ban on finished products applies since September 2004. The testing ban on ingredients or raw materials applies since March 2009. Also, a marketing ban applies since March 2009 for all human health effects with the exception of repeated-dose toxicity, reproductive toxicity and toxicokinetics for the EU market.
However, all historical animal data can still be used and be relied on for the drafting of cosmetic safety assessment or to fill a data gap for toxicological endpoint such as skin irritation.
Regarding animal experimentation, the PIF must include data related to tests on animals that were carried out by the manufacturer, its staff or its providers.
Name and address of the Responsible Person
Country of origin
Nominal content
Date of minimum durability or period-after-opening
Precautions & warnings*
Batch number
Product function*
Ingredients list
*Translation in the language of the export country is mandatory. Some countries require full translation of the label, i.e. even the marketing content and claims.
Statements must appear visibly, legibly and indelibly on the label.
The hourglass symbol to illustrate the Date of Minimum Durability (DOMD) when equal or below 30 months. The DOMD is defined by the stability test. You must add date near the symbol
If the DOMD exceeds 30 months, the open-jar symbol will indicate the Period After Opening "PAO” defined by the combination of the stability test and challenge test.
The hand-in-book symbol will indicate to the consumer that a card, tag or leaflet is enclosed with the product with more regulatory information.
Last but not least, the Responsible Person must notify the European Commission via the CPNP portal, a website that Responsible Persons and Authorities can use to access products’ information. Regulation No 1223/2009 requires that any company willing to place a cosmetic product on the market must notify online before doing so.
What must be transmitted at the time of notification?
Only one notification is needed for all 31 countries of the European Economic Area (EEA).
This blog post was originally published on EcoMondo
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